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Adenoid HypertrophyNCT06674720

It is Accepted That Adenoid Hypertrophy is Related to Otitis Media With Effusion Incidence. Better Understanding of the Correlation Between the Relative Size of AH and the Incidence of Persistent OME May Provide Evidence to Support a More Standardized Approach to the Diagnosis and Treatment of OME.

An observational study of Adenoid Hypertrophy and Middle Ear Effusion, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The aim of this study is to further investigate the correlation between Site and size of adenoid hypertrophy and middle ear effusion in order to provide evidence for designing a more standardized approach to the diagnosis and treatment of OME. Read more about this study

Who is it for?
Ages 1 year to 16 yearsHealthy volunteers can take part
Conditions the study is for
Adenoid Hypertrophy, Middle Ear Effusion
How many people
60 participants
Where
No sites listed yet
Study dates
May 2025to Dec 2027
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Children age group (from 1 year old till 16 years old), male and female are included, with symptoms and signs of adenoid hypertrophy

Who may be able to join

  • Children (until age of 16 years old).
  • Patients with adenoid hypertrophy.
  • Patients with OME.

Who cannot join

  • Children known to have cleft palate, submucous cleft palate or other medical problems causing velopharyngeal insufficiency.
  • Down's syndrome, septal deviation, primary ciliary dyskinesia (Kartagener's syndrome), previous head or ear trauma, or previous myringotomy with ventilation tube insertion
  • Systemic medical problems interfering with surgery.
  • Refusal of parents to participate.
  • Craniofacial abnormalities.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Esraa A Mohamed, Bachelor's contact

+201122736706

esraa.aboalqasem@gmail.com

Mohamed O Gad, Professor contact

+201227006258

Omargad@gmail.com

About this study

Official title: Correlation of Site and Size of Adenoid Hypertrophy and Middle Ear Effusion.

The aim of this study is to further investigate the correlation between Site and size of adenoid hypertrophy and middle ear effusion in order to provide evidence for designing a more standardized approach to the diagnosis and treatment of OME.

Read the detailed description

The adenoid, or the pharyngeal tonsil, is an antibody producing lymphatic tissue located in the superior part of the nasopharynx posteriorly, near the choana and opening of the eustachian tube. They are present from the seventh month of gestation and typically grow until age 5. Adenoid tissue can be found extending to the eustachian tube opening and the fossa of Rosenmuller. The fossa of Rosenmuller is on the lateral wall of the nasopharynx, just behind the cartilage of the eustachian tube.

It grows during childhood, appearing largest in size in children between 3 and 7 years of age, and begins to regress in adolescence. Children younger than 7 years are more prone to symptomatic effects of enlarged adenoid due to the relatively smaller volume of the nasopharynx and choanal opening. The prevalence of AH (pathologic enlargement) follows physiologic growth and regression pattern of the adenoid. An enlarged adenoid may block breathing and be a cause of snoring or obstructive sleep apnea. Adenoid hypertrophy can also lead to comorbid conditions such as serous otitis and sinusitis. AH is higher in frequency in children with allergic diseases, with the most common allergen being house dust. Other risk factors noted for developing AH include cigarette smoke exposure and allergic rhinitis. In a child with these risk factors, AH should be a consideration during a routine examination. Assessing adenoidal size can be achieved initially by lateral neck radiography (LNR) and assessing adenoid-nasopharyngeal ratio (A/N ratio) which is one of the most important and most widely used criteria. Although these methods are inexpensive and available, they have limited role in the exact assessment of areas such as the ears. Flexible nasal endoscopy, where adenoid size grading is on a scale of I to IV identifies the percentage of the posterior choana blocked by the adenoid tissue, with grade IV representing the highest level of obstruction.

AH influence on the pathogenesis of OME is two-fold: it may mechanically obstruct the Eustachian tube, and its vegetation may serve as a reservoir of biofilm forming bacteria causing retrograde infections towards the Eustachian tube and the middle ear.

Otitis media with effusion (OME) is a disease defined by persistence of serous or mucous fluid in middle ear without signs of an acute infection. It is amongst the most common pediatric diseases and the most common cause of hearing loss in children. It is estimated that more than 50% of children are diagnosed with OME by the age of 1 year, and up to 90% of children by the time they have reached school age.

Although the exact pathogenesis of OME is not clearly understood, it is generally resulted from lymphoid tissue overgrowth in nasopharynx, chronic sinus infection, and allergies.

It is accepted that adenoid hypertrophy (AH) is related to OME incidence. Better understanding of the correlation between the relative size of AH and the incidence of persistent OME may provide evidence to support a more standardized approach to the diagnosis and treatment of OME.

It is accepted that adenoid hypertrophy (AH) is related to OME incidence. Better understanding of the correlation between the relative size of AH and the incidence of persistent OME may provide evidence to support a more standardized approach to the diagnosis and treatment of OME.

There is sufficient evidence that AH is an important co-factor in the development of OME, a very consequential disease.

Medical subject headings
Otitis Media with Effusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparing presence of middle ear effusion in relation to site and size of adenoid hypertrophy

    The incidence of OME with each AH grade occurring in each age group of the sample size.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2024
  2. Study startMay 2025 (estimated)
  3. Primary completionMay 2025 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06674720
Sponsor's protocol ID
Adenoid hypertrophy and MEE
Status last verified
Jan 2025
First submitted
30 Sep 2024
Last updated
17 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mnatsakanian A, Heil JR, Sharma S. Anatomy, Head and Neck: Adenoids. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK538137/

    PubMed 30844164
  • Khadgi A, Koirala K, Maharjan S, Chalise K, Dhungana I, Babu Karki B. Correlation of Conductive Hearing Impairment With Sizes of Adenoids in the Pediatric Age Group: An Observational Case-Control Study. Cureus. 2023 Aug 31;15(8):e44439. doi: 10.7759/cureus.44439. eCollection 2023 Aug.

    PubMed 37791228
  • Niedzielski A, Chmielik LP, Mielnik-Niedzielska G, Kasprzyk A, Boguslawska J. Adenoid hypertrophy in children: a narrative review of pathogenesis and clinical relevance. BMJ Paediatr Open. 2023 Apr;7(1):e001710. doi: 10.1136/bmjpo-2022-001710.

    PubMed 37045541
  • Ohuche IO, Iloanusi NI, Dike CM, Chime EN. Clinical presentation, radiographic findings, and treatment outcomes in children with adenoid hypertrophy in a paediatric outpatient clinic in Enugu, Nigeria. Ghana Med J. 2023 Sep;57(3):204-209. doi: 10.4314/gmj.v57i3.7.

    PubMed 38957679
  • Galic MZ, Klancnik M. ADENOID SIZE IN CHILDREN WITH OTITIS MEDIA WITH EFFUSION. Acta Clin Croat. 2022 Feb;60(3):532-539. doi: 10.20471/acc.2021.60.03.25.

    PubMed 35282481

Questions about this trial

What is this clinical trial studying?

An observational study of Adenoid Hypertrophy and Middle Ear Effusion, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Esraa A Mohamed, Bachelor's (+201122736706, esraa.aboalqasem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparing presence of middle ear effusion in relation to site and size of adenoid hypertrophy (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06674720, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.

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